ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 is an FDA 510(k)-cleared medical device (K102887) manufactured by Percutaneous Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2011. Regulation: 8.